Our Review Summary
This news release describes a head-to-head trial of two acne medications. The trial design sounded impressive; it was randomized, double-blind and placebo controlled. But that intro was the best the release had to offer readers. There were no details from the study to back up subsequent claims. This news release has a lot of what we don’t want to see in a news release — fear mongering, hype, unjustifiable language, and lack of evidence.
Why This Matters
Acne is the most common skin disorder in the US affecting between 40-50 million persons of all ages and races. This chronic inflammatory disease, when untreated, can lead to physical scars, skin hyperpigmentation, and psychological problems. It primarily affects adolescents and teens. There are multiple OTC and mail-order (direct to consumer) formulations (including antimicrobial agents and cleansers) and it is a huge business (>1billion dollars annually). In an era where appointments with pediatricians, family physicians and dermatologists are not so easy to come by, buying OTC products is a great option if they work.
Criteria
Not Satisfactory
There is no mention of cost in the release, not even a mention of where this new product will be on the spectrum of OTC products via-a-vis price. For a product whose manufacturer boasts in the release that it will come out of the gate to become a global competitor, one would expect they’d have a price point to offer.
Not Satisfactory
We’re told that “After 24 hours treatment, the percentage of subjects with reduced acne count was 64% greater for those using HSRx 2121 than for subjects using the competing product.” Various other relative comparisons are provided that are all about as clear as mud since they don’t contain any absolute numbers. Example: “the percentage of subjects with unsightly acne-associated redness was reduced nearly three times as much…” Three times as much as what?
Not Satisfactory
Harms are not mentioned. Most OTC acne medications come with a warning to start slowly with small amounts until you know how your skin will react. Common side effects include dryness, redness, peeling, itching, burning, and rashes.
Not Satisfactory
Nice try describing this as a ‘head-to-head’ comparison and a “randomized controlled trial.” Alas, there is more we don’t know (and need to know!) than what is revealed here.
- We are not told what type of acne this was used for (non-inflammatory, mild, moderate? assuming not severe).
- We are not told what their treatment contains (antimicrobials? anti-inflammatory? cleansers? retinoids?) and what they are comparing themselves to. OTC formulations can have: 1) different components/ingredients 2) one product that contains multiple components, 3) different modes of delivery (gel vs. cream vs. lotion vs. foam)…each has a different “bioavailability”, 4) different concentrations (for the same ingredient), 5) different dosing requirements (once a day, vs. twice a day, etc). For all we know, they could have compared their topical gel (often more effective) that contains two or more ingredients, and used 2-3 times a day vs. a single, low dose ingredient, used once-daily and provided as a cream.
- This could be a situation of comparing apples to oranges. Even without mentioning the product of the competition, they could have mentioned the ingredients in the comparison.
- Additionally, though it is great to hear this was a randomized-controlled trial, we are not given any information about the “90 subjects”: are they of similar skin types, ethnicities, type of acne, gender, comorbidities? Any of these factors (and more) could affect the results.
- Also, curiously, this is supposedly a “placebo controlled comparative clinical.” yet they don’t report on the placebo group. We only hear about their product vs. the “competing product”. What if the placebo group had similar results?
Not Satisfactory
There is a fair amount of fear mongering here. The release calls acne “a universal plague”, “unsightly” and even cites a NASA “warning” about acne bacteria living on the International Space Station! (The release links, by the way, to a story in the UK Daily Mirror — not exactly a credible news source.) For the record, NASA itself never produced a “warning” as stated in the release. Its scientists merely described all kinds of organisms found on the ISS which, not surprisingly, include bacteria that live on human bodies (http://microbiomejournal.biomedcentral.com/articles/10.1186/s40168-015-0116-3).
The release also refers to acne as “among the 10 most prevalent human infectious diseases” as if it were some deadly virus or bacteria. Though bacteria does play a role in acne, it is, in fact, better known as an inflammatory condition and bacteria is but one pathophysiological mechanism responsible for it.
Satisfactory
We’ll give the benefit of the doubt here. The release states that the trial was conducted by their pharma company HSRx Group and speaks openly about marketing. In fact, most of the release talks about what a great business opportunity it is and the potential for profit (vs. how it might impact the millions of sufferers): “The HSRx product demonstrated superior treatment performance throughout the entire clinical study.”That makes for a powerful marketing advantage,” Sullivan said.” And: “Our acne treatment product has enormous commercial potential, evidenced by the significant licensee interest it has attracted. As with each of our next generation OTC drug products, we intend to license HSRx 2121 to a leading marketing entity that has the resources and expertise to maximize sales, here and abroad,” Parise said.”
If you go to the website of the research organization you will find their acne study summaries (which interestingly DO mention the types of acne formulations used). Makes one wonder even more why the news release neglected to mention this.
Not Satisfactory
This was the release’s greatest omission. The release is about a head-to-head trial but does not name one of the two products being tested.
In the FDA-approved OTC acne product realm there are many brand names but only four basic medications that are sold alone or in combination. They are benzoyl peroxide, salicylic acid, alpha hydroxy acids and sulfur.
There are many OTC and many prescription medications most of which use the basic ingredients in multiple different ways and combinations. There are also several non-medication types of interventions such as laser therapy, acupuncture, etc, used frequently for acne.
Not Satisfactory
The release doesn’t state if the product is available now or when it might become available.
Not Satisfactory
We don’t know if this is a novel compound or not since we don’t know what’s in it. We get no useful information here about what’s in the formulation and why is it new (type of ingredient, new dose, novel delivery model? new combo of existing ingredients?).
Not Satisfactory
It is inappropriate and unjustifiable to include acne “among the 10 most prevalent human infectious diseases” when threats like HIV/AIDS, tuberculosis, influenza, Ebola are deadly, unlike acne, and in a whole other class of disease.
The strong claims made without providing data on the comparison product are completely unjustified.
“The HSRx product demonstrated superior treatment performance throughout the entire clinical study.”
We also get hyped statements about NASA acne warnings, and we’re troubled by the highlighted outcome being the profit potential and NOT patient-oriented outcomes (and reduction in suffering).
Total Score: 1 of 10 Satisfactory
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